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FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway
Date:5/11/2009

PARSIPPANY, N.J., May 11 /PRNewswire-FirstCall/ -- Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on oncology therapeutics, today announced that the U.S. Food and Drug Administration ("FDA") accepted the Company's Investigational New Drug ("IND") application for the use of AR-12, a potentially first-in-class, orally available, PDK1 inhibitor that blocks the PI3K/Akt pathway and induces the endoplasmic reticulum stress pathway. Acceptance of the IND permits Arno to initiate a Phase I clinical trial in adults with advanced or recurrent solid tumors or lymphoma for which no standard therapy is available. Arno expects the Phase I clinical trial to begin during the second half of 2009 and will be designed to assess the safety and early evidence of activity of AR-12.

"We are excited that AR-12 has received IND acceptance by the FDA allowing us to begin our Phase I studies. Our preclinical data has demonstrated that AR-12 is active in a wide range of tumor types and it also shows promising activity in combination with several widely used approved cytotoxic as well as molecularly targeted anti-cancer agents," stated Dr. Roger G. Berlin, Chief Executive Officer of Arno.

About AR-12

AR-12 is a potentially first-in-class, orally available, PDK1 inhibitor that blocks the PI3K/Akt pathway and induces the endoplasmic reticulum stress pathway.

About Arno Therapeutics

Arno Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops and commercializes innovative products for the treatment of cancer patients. Arno's lead clinical development compound is AR-67, a novel, third-generation camptothecin analogue which has completed patient enrollment of its Phase I studies in patients with advanced solid tumors, that has demonstrated high preclinical potency and improved pharmacokinetic properties when compared with marketed second-g
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SOURCE Arno Therapeutics, Inc.
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